Remote Monitoring of IBD

Last updated: May 23, 2023
Sponsor: Maastricht University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Inflammatory Bowel Disease

Bowel Dysfunction

Treatment

fecal calprotectin

colonoscopy

patient reported outcome measures

Clinical Study ID

NCT05886322
NL75205.068.20
NL9313
  • Ages > 18
  • All Genders

Study Summary

Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) with a heterogeneous disease course. Recurrent mucosal inflammation or chronic subclinical inflammation results in damage to the bowel and complications like stenosis, fistula and colorectal cancer. Therefore, tight control of mucosal inflammation is important to prevent complications.

The goal of this multicenter observational cohort study is to determine the best remote monitoring tool for predicting mucosal inflammation in adult patients with inflammatory bowel disease, relative to the gold standard endoscopy.

Participants will be asked to fill out questionnaires regarding disease activity (MIAH, mHI, IBD-control, Manitoba IBD Index, p-HBI/p-SCCAI), perform a FC home test and collect one stool sample for routine laboratory calprotectin measurement, before the start of the bowel preparation for the ileocolonoscopy. During this ileocolonoscopy, endoscopic disease activity will be determined.

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Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Established diagnosis of CD or UC according to ECCO guidelines
  • CD or UC patients scheduled for an ileocolonoscopy, or UC patients scheduled for ansigmoidoscopy at the endoscopy ward of one of the participating centers (regardless ofindication)
  • Aged 18 years or older
  • Smartphone with internet access (for use FC home test)

Exclusion

Exclusion Criteria:

  • Unclassified IBD
  • Ileostomy, colostomy, ileoanal pouch anastomosis or ileorectal anastomosis
  • Isolated upper gastro-intestinal CD, or isolated peri-anal disease
  • Insufficient knowledge of Dutch language

Study Design

Total Participants: 400
Treatment Group(s): 3
Primary Treatment: fecal calprotectin
Phase:
Study Start date:
June 07, 2022
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Jeroen Bosch Hospital

    Den Bosch,
    Netherlands

    Active - Recruiting

  • Catharina Hospital Eindhoven

    Eindhoven,
    Netherlands

    Site Not Available

  • Maastricht University Medical Centre

    Maastricht,
    Netherlands

    Active - Recruiting

  • Franciscus Gasthuis&Vlietland

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Zuyderland Medical Centre

    Sittard,
    Netherlands

    Site Not Available

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